Evaluation Of A Virtual Cardiology Program To Improve Outcomes After Acute Decompensated Heart Failure (ELEVATE-HF)

Duke University

Status: Active, not recruiting

Conditions: Heart Failure; With Decompensation

Treatments: Other: Remote Virtual Cardiology Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06592508

Pro00115672

Details and patient eligibility

About

The purpose of this study is to evaluate how safe and effective a remote, virtual, cardiology program is that provides heart failure education to patients, monitors for worsening heart failure, and quickly adjusts heart failure medications, compared to usual care medication use and adjustment, in participants with decompensated heart failure that are recently hospitalized.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years of age
• Acute decompensated HF as a primary cause of hospitalization. Hospitalizations for acute decompensated HF will be determined by local clinician-investigators but should include findings of acute HF (i.e., symptoms, signs, and/or laboratory/imaging abnormalities) and treatments aimed at acute HF (e.g., intravenous diuretics, vasodilators, or inotropes). Participants with a new diagnosis of HF may be enrolled. The enrollment will be monitored to ensure no more than 2/3 of the total cohort has new-onset HF.
• Fluent in written and spoken English

Exclusion criteria

• Optimized or nearly optimized on evidence-based medical therapies for HF as determined by local investigator
• Current pregnancy
• Chronic use of intravenous inotropic medications including milrinone, dobutamine, or dopamine
• eGFR of <20 mL/min/1.73m2 ongoing chronic dialysis at screening. The eGFR should be estimated using the 2021 Chronic Kidney Disease Epidemiology Collaboration (2021 CKD-EPI) creatinine equation.
• History of prior heart transplant or currently listed for heart transplant
• Current left ventricular assist device or planned left ventricular assist device in the next 6 months
• Currently receiving hospice care
• Chronically resides in an assisted living or skilled nursing facility where medications are managed by facility personnel
• Terminal illness other than HF with a life expectancy of <1 year as determined by the enrolling clinician-investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Experimental: Remote Virtual Cardiology Program

Experimental group

Description:

The Ventricle Health program will remotely receive daily vital signs directly from a blood pressure cuff and scale provided to the participant. In addition, the program will also remotely receive oxygen levels and electrical heart activity directly from a Pulse Ox and an EKG Single-Lead monitor, provided to the participant. All of this data will be transmitted to the Ventricle Health program. The Ventricle Health team, consisting of Cardiologists and clinical staff, will use this data to titrate medications and make clinical decisions.

Treatment:

Other: Remote Virtual Cardiology Program

Usual Care

No Intervention group

Description:

Routine clinical care will be followed. Participants should be recommended for the best possible outpatient heart failure care at each site.